K233814
- 510(k) number
- K233814
- Device name
- 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M)
- Applicant
- 3M Company MN · US
- Product code
- FRC — Indicator, Biological Sterilization Process
- Decision date
- 2024-03-15
- Date received
- 2023-11-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain
Also available from FDA: K233814.pdf
Official FDA record: K233814
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.